Vaccess® VA8064RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741059872), received between Feb 13, 2017 and Jan 8, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2019Break; Retraction Problem; Material Rupture; Break; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT ARM, THE PTA BALLOON ALLEGEDLY RUPTURED CIRCUMFERENTIALLY. REPORTEDLY, THE HEALTH CARE PROVIDER MADE A LARGER INCISION TO REMOVE THE BALLOON AND SHEATH AS ONE UNIT. THE PROCEDURE WAS CONCLUDED, AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8226690 ↗
• MalfunctionFeb 13, 2017Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY WOULD NOT INFLATE. IT WAS FURTHER REPORTED THAT UPON RETRACTION FROM THE PATIENT, THE HEALTH CARE PROVIDER ATTEMPTED TO INFLATE THE BALLOON AGAIN AND IT WAS ABLE TO BE INFLATED SLIGHTLY; HOWEVER, IT WAS THEN UNABLE TO BE DEFLATED. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6327519 ↗